(204 days)
The LED Eye Perfector (Model: EY-36A, EY-36B) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.
The LED Eye Perfector, model: EY-36A and EY-36B is an over-the-counter light-emitting diode (LED) device that emits energy for dermatology to treat wrinkles within the periorbital region. The device uses four types of LEDs, and for model EY-36A: 605 nm, 633 nm, 660nm, 830 nm, for EY-36B: 605 nm, 625 nm, 660nm, and 880 nm. The treatment time can be controlled by the user, or automatically shut off within a set time. The LED Eye Perfector components contain the main unit device, charging base, USB charging cord, velcro straps and goggles. There is a total of 40 LEDs to provide a power intensity of about 65 mW/cm². The user wears the device on their eye area for the treatment, and the device will shut down automatically after a 3-minute after finishing treatment. There are no differences between the two models other than the output wavelength.
The provided 510(k) summary for the LED Eye Perfector device (K221444) does not contain information about studies measuring the device's performance against clinical acceptance criteria. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and adherence to safety standards, rather than proving direct clinical efficacy or performance against specific metrics like sensitivity or specificity.
The "Test Summary" section (page 7) lists various safety and performance standards (e.g., electrical safety, electromagnetic compatibility, biocompatibility) to which the device was evaluated. These are engineering and safety tests, not clinical performance studies for efficacy in treating wrinkles.
Therefore, I cannot fulfill the request to describe acceptance criteria and study results related to clinical performance because the provided document does not include such information.
To elaborate on the specific points requested:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on compliance with general safety and electrical standards, not on clinical performance metrics like "wrinkle reduction percentage" or "satisfaction rates."
- Sample sizes used for the test set and the data provenance: Not applicable for clinical performance. The "test set" in this document refers to the device itself undergoing engineering and safety evaluations, not a patient cohort.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical efficacy is not discussed.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an LED-based treatment, not an AI diagnostic or assistance tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a therapeutic device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical efficacy. The "ground truth" implicitly used for the safety and engineering tests is compliance with the specified international standards.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a Class II medical device based on engineering and safety standards, and comparison to legally marketed predicate devices. It does not include data from clinical performance studies against specific acceptance criteria for wrinkle reduction.
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December 8, 2022
Light Tree Ventures Europe B.V. Kim Laurens Manager Laan van Ypenburg 108, 2497 GC The Hague, Netherlands
Re: K221444
Trade/Device Name: LED Eye Perfector, model: EY-36A, EY-36B Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHS Dated: November 10, 2022 Received: November 10, 2022
Dear Kim Laurens:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the text "Jianting Wang -S" in a large, bold font. The text is black and appears to be centered. The background is white, and there is a faint watermark behind the text.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221444
Device Name LED Eye Perfector (Model: EY-36A, EY-36B)
Indications for Use (Describe)
The LED Eye Perfector (Model: EY-36A, EY-36B) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary of K221444
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Sponsor Name: Light Tree Ventures Europe B.V. Establishment Registration Number: 3017422691 Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Contact Person (including title): Alain Dijkstra (Manager) Tel: +86-135-10378748 Fax: +86-755-25024651 E-mail: regulation@kaiyanmedical.com
Distributor
Company Name: CurrentBody.com Ltd Address: Unit D6, Stanley Green Business Park, Commercial Avenue, Cheadle Hulme SK8 6QH
Factory
Company Name: Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building 3, No.40, Fuxin street, Huaide Community, Fuyong Town,Baoan District, Shenzhen, Guangdong, 518103, China
Application Correspondent:
Contact Person: Alain Dijkstra Company: Light Tree Ventures Europe B.V. Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Tel: +86 755 82129361 Fax: +86 755 25024651 Email: regulation@kaiyanmedical.com
2. Subject Device Information
Trade Name: LED Eye Perfector, model: EY-36A, EY-36B Trademark: CurrentBody SkinTM Classification Name: Light Based Over-The-Counter Wrinkle Reduction Review Panel: General & Plastic Surgery Product Code: OHS
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Regulation Number: 21 CFR 878.4810 Regulation Class: II
3. Predicate Device Information
Predicate Device (Primary comparison device) Sponsor: LED Technologies, Inc Trade Name: dpl® SpectraLite Classification Name: Light Based Over-The-Counter Wrinkle Reduction Common Name: dpl® SpectraLite 510(K) Number: K171386 Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810 Regulation Class: II
Predicate Device (Second comparison device)
Sponsor: Zhongshan Bisen Plastic Electronic Products Co., Ltd. Trade Name: RED Light Device Classification Name: Light Based Over The Counter Wrinkle Reduction Common Name: Light Emitting Diode (LED) Device 510(K) Number: K162489 Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810 Regulation Class: II
4. Device Description
The LED Eye Perfector, model: EY-36A and EY-36B is an over-the-counter light-emitting diode (LED) device that emits energy for dermatology to treat wrinkles within the periorbital region. The device uses four types of LEDs, and for model EY-36A: 605 nm, 633 nm, 660nm, 830 nm, for EY-36B: 605 nm, 625 nm, 660nm, and 880 nm. The treatment time can be controlled by the user, or automatically shut off within a set time.
The LED Eye Perfector components contain the main unit device, charging base, USB charging cord, velcro straps and goggles.
There is a total of 40 LEDs to provide a power intensity of about 65 mW/cm².
The user wears the device on their eye area for the treatment, and the device will shut down automatically after a 3-minute after finishing treatment.
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There are no differences between the two models other than the output wavelength.
5. Intended Use / Indications for Use
The LED Eye Perfector (Model: EY-36A, EY-36B) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.
6. Comparison to predicate device and conclusion
Compare with the predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between the subject device and predicate devices do not raise new questions of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device(Primarycomparisondevice) | PredicateDevice (Secondcomparisondevice) | Remark | |
|---|---|---|---|---|---|
| Company | Light Tree Ventures Europe B.V. | LED Technologies, Inc | ZhongshanBisen PlasticElectronicProducts Co.,Ltd. | -- | |
| Trade Name | LED Eye Perfector | dpl® SpectraLite | RED LightDevice | -- | |
| Model | EY-36A EY-36B | EY-40 | BZ-0606 | -- | |
| Classification Name | Light Based Over-The-Counter WrinkleReduction | Light Based Over-The-CounterWrinkle Reduction | Light BasedOver TheCounter WrinkleReduction | Same | |
| 510(k) Number | Applying | K171386 | K162489 | -- | |
| Product Code | OHS | OHS | OHS | Same | |
| Intended Use /Indications for Use | The LED Eye Perfector(Model: EY-36A, EY-36B) is an Over-the-Counter (OTC) deviceintended for use intreating wrinkles withinthe periorbital region. | The dpl®SpectraLite is anOver-the-Counter(OTC) deviceintended for use intreating wrinkleswithin the | The RED LightDevice is anOTC deviceindicated to emitenergy in the redand IR region ofthe spectrum for | Same | |
| periorbital region. | use indermatology forthe treatment ofperiorbitalwrinkles. | ||||
| Power Supply | Main unit: 3.7V, 420mAhlithium battery, 1.55WhAdapter Input: 100-240Va.c., 50/60HzAdapter Output: 5Vd.c,1A | 120-240V 5VDCPowerAdapter | Adaptor:100~240V AC 50/60HzLithium battery:2x3.7V | SimilarNote 1 | |
| Wavelengths | 605 nm,633 nm,660nm,830 nm | 605 nm,625 nm,660nm,880 nm | 605 nm, 625 nm,660nm,880 nm | Red: 633 ±5nmInfrared: 830±5nm | SimilarNote 2 |
| Modes | On/Off | On/Off | Not applicable | Same | |
| Irradiance source | LED | LED | LEDs | Same | |
| Visible light LEDs | Yes | Yes | Yes | Same | |
| Treatment Area | 40 cm² | 28 cm² | 17cm² | DifferentNote 2 | |
| Energy Level | 65 mW/cm² | 61.59 mW/cm² | 125 mW/cm²70 mW/cm²(633 nm);55 mW/cm²(830 nm) | DifferentNote 2 | |
| LED distribution | Uniformdistribution | Uniformdistribution | Uniform distribution | No publicity | Same |
| Treatment Time | 3 minutes per treatment | 3 minutes pertreatment | For the firstmonth (4weeks),treatment shouldbe performed 3times a week for15-20 minutes | Same | |
| each time. (5-7minutes on eachtreatment zone). | |||||
| Target Population | Individuals with wrinkleson their face within theperiorbital region. | Individuals withwrinkles on theirface within theperiorbital region. | Individuals withperiorbital linesand wrinkles | Same | |
| Location for USE | OTC | OTC | OTC | Same | |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same | |
| Safety | IEC 60601-1IEC 60601-2-57IEC 60601-1-11IEC 62471 | IEC 60601-1,IEC 62471 | IEC 60601-1IEC 60601-2-57IEC 60601-1-11IEC 62471 | Same | |
| Biocompatibility | ISO 10993-1ISO 10993-5ISO 10993-10 | ISO 10993-1,ISO 10993-5,ISO 10993-10 | ISO 10993-1,ISO 10993-5,ISO 10993-10 | Same |
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Comparison in Detail(s):
Note 1: Although the "Power Supply" is a little different from the predicate devices, they all complied with the IEC 60601-1 and IEC 60601-1-2 safety standards' requirements. So, these slight differences will not raise any safety or effectiveness issues.
Note 2: Although the "Wavelengths", "Treatment Area" and "Energy Level" are a little different from the predicate devices, they all complied with the IEC 60601-1-2, IEC 60601-2-57, and IEC 62471 safety standards' requirements. So, these slight differences will not raise any safety or effectiveness issues.
7. Test Summary
LED Eye Perfector (Model: EY-36A, EY-36B) has been evaluated the safety and performance by lab bench testing as following:
| Standards No. | Standard Title | Version | Date | Recognition Number |
|---|---|---|---|---|
| ANSI AAMIES60601-1 | Medical electrical equipment -Part 1: General requirementsfor basic safety and essentialperformance | 2005/(R)2012 andA1:2012,C1:2009/(R)2012 andA2:2010/(R)2012 | 07/09/2014 | 19-4 |
| IEC 60601-1-11 | Medical electrical equipment -Part 1-11: Generalrequirements for basic safetyand essential performance -Collateral Standard:Requirements for medicalelectrical equipment andmedical electrical systemsused in the home healthcareenvironment | Edition 2.1 2020-07 | 12/21/2020 | 19-38 |
| IEC 60601-2-57 | Medical Electrical Equipment- Part 2-57: Particularrequirements for the basicsafety and essentialperformance of non-laserlight source equipmentintended for therapeutic,diagnostic, monitoring andcosmetic/aesthetic use | Edition 1.0 2011-01 | 03/16/2012 | 12-242 |
| IEC 60601-1-2 | Medical electrical equipment -Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral Standard:Electromagnetic disturbances- Requirements and tests | Edition 4.1 2020-09 | 12/21/2020 | 19-36 |
| IEC 60601-1-6 | Medical electrical equipment -Part 1-6: Generalrequirements for basic safetyand essential performance -Collateral standard: Usability | Edition 3.2 2020-07 | 12/21/2020 | 5-132 |
| IEC 62471 | Photobiological safety oflamps and lamp systems | First edition 2006-07 | 08/20/2012 | 12-249 |
| IEC 62133-2 | Secondary cells and batteriescontaining alkaline or othernon-acid electrolytes - Safetyrequirements for portablesealed secondary cells, andfor batteries made from them,for use in portableapplications – Part 2: Lithiumsystems | Edition 1.0 2017-02 | 12/23/2019 | 19-33 |
| ISO 10993-5 | Biological evaluation ofmedical devices - Part 5:Tests for in vitro cytotoxicity | Third edition 2009-06-01 | 12/23/2016 | 2-245 |
| ISO 10993-10 | Biological evaluation ofmedical devices - Part 10:Tests for irritation and skinsensitization | Third Edition 2010-08-01 | 07/26/2016 | 2-174 |
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8. Date of the summary prepared: November 10, 2022
9. Final Conclusion:
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K171386 and K162489.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.